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Beyond the regulatory requirement to perform them, regular internal audits can benefit quality, productivity and an organization’s bottom line. But if you’re simply going through the motions of an internal audit to check that regulatory box or if you’re not properly analyzing the data that comes out of those audits, you’re missing a real opportunity, says quality expert says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More
Medtronic’s June recall of its Mahurkar Acute Triple Lumen and Mahurkar Acute High Pressure Triple Lumen Catheters, the third recall of the company’s hemodialysis catheters in a year, has been deemed class I by the FDA, because use of the device could cause serious injury or death. Read More
Recent clearances and approvals of medical devices include not just new versions of existing products, but entirely different ways to provide care for both complex illnesses and common needs. Read More
The FDA has reprimanded AstraZeneca for making false and misleading claims about its chronic lung inflammatory inhalation therapy Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate), while the agency has also smacked Denison, CalmCo and ALVA-AMCO Pharmaceutical Companies for selling unapproved drugs and good manufacturing practice (GMP) violations. Read More
Make sure to submit electronic or written comments on a guidance by the closing date is the first tip given by CDRH in a list, released Aug. 16, of tips, recommendations and instructions on how to submit comments on a guidance. Read More
A July 10-20 FDA inspection of a Biocon manufacturing facility in Malaysia turned up eight observations including a repeat observation of failure to follow procedures that prevent microbiological contamination of drugs intended to be sterile, and inadequate review and investigation of failed batches. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and a webinar from FDAnews, a WCG company on medical device risk management tools. Read More
Amgen and Horizon have launched a return volley in their battle with the FTC, asking the U.S. District Court of Northern Illinois to deny the FTC’s July motion that sought to strike down arguments that Amgen and Horizon’s constitutional defenses are legitimate considerations in the case. Read More
In a recent court filing, HHS lambasted the U.S. Chamber of Commerce’s recent call to slow down implementation of pricing negotiations within the Inflation Reduction Act (IRA), calling the group’s efforts “hyperbolic” and accusing it of just trying to lobby Congress in court to stop the Act’s efforts to drive down the cost of prescription drugs. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. Read More
The FDA has classified the most recent recall of certain Philips Trilogy ventilators as class I, the most serious type of recall as use of the device may lead to serious injury or death. Read More
Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear responsibility for continued safe and effective performance of the device. Read More